Preclinical Assessment of HIV Vaccines and Microbicides by Repeated Low-Dose Virus Challenges 英文参考文献.docVIP

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Preclinical Assessment of HIV Vaccines and Microbicides by Repeated Low-Dose Virus Challenges 英文参考文献.doc

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Preclinical Assessment of HIV Vaccines and Microbicides by Repeated Low-Dose Virus Challenges 英文参考文献

o Openaccess,freelyavailableonline PL S MEDICINE PreclinicalAssessmentofHIVVaccines andMicrobicidesbyRepeatedLow-DoseVirus Challenges Roland R.Regoes1*,IraM. Longini, Jr.2,Mark B.Feinberg3,4,Silvija I.Staprans3 1 Department of Biology, Emory University, Atlanta, Georgia, United States of America, 2 Department of Biostatistics, Rollins School of Public Health, Emory University, Atlanta,Georgia,UnitedStatesofAmerica,3DepartmentsofMedicineandMicrobiologyandImmunology,EmoryUniversitySchoolofMedicineandtheEmoryVaccine Center,Atlanta,Georgia,UnitedStatesofAmerica,4MerckVaccineDivision,Merck,WestPoint,Pennsylvania,UnitedStatesofAmerica CompetingInterests:Theauthors havedeclaredthatnocompeting interestsexist. ABSTRACT Background AuthorContributions:RRR performedtheanalysis.RRR,IML, MBF,andSISdesignedthestudyand wrotethepaper. Trialsinmacaquemodelsplayanessentialroleintheevaluationofbiomedicalinterventions that aim to prevent HIV infection, such as vaccines, microbicides, and systemic chemo- prophylaxis.Thesetrialsareusuallyconductedwithveryhighviruschallengedosesthatresult ininfectionwithcertainty.However,thesehighchallengedosesdonotrealisticallyreflectthe lowprobabilityofHIVtransmissioninhumans,andthusmayruleoutpreventiveinterventions that could protect against ‘‘real life’’ exposures. The belief that experiments involving realistically low challenge doses require large numbers of animals has so far prevented the developmentofalternativestousinghighchallengedoses. AcademicEditor:MarcLipsitch, HarvardSchoolofPublicHealth, UnitedStatesofAmerica Citation:RegoesRR,LonginiIMJr, FeinbergMB,StapransSI(2005) PreclinicalassessmentofHIV vaccinesandmicrobicidesby repeatedlow-doseviruschallenges. PLoSMed2(8):e249. MethodsandFindings Using statistical power analysis, we investigate how many animals would be needed to conductpreclinicaltrialsusinglowviruschallengedoses.Weshowthatexperimentaldesigns in which animals are repeatedly challenged with low doses do not require unfeasibl